URELLE - hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate and sodium phosphate, monobasic, monohydrate tablet 
Azur Pharma Inc.

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Urelle® Urinary Antiseptic

DESCRIPTION

Urelle® tablets for oral administration are supplied as navy blue round tablets with “A-002” debossed on one side.

Each Tablet Contains:

Hyoscyamine Sulfate 0.12 mg

Methenamine 81.0 mg

Methylene Blue 10.8 mg

Phenyl Salicylate 32.4 mg

Sodium Phosphate Monobasic 40.8 mg

INACTIVE INGREDIENTS

Corn Starch, Dicalcium Phosphate, FD&C Blue #2/Indigo Carmine Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Talc, Titanium Dioxide.

INDICATIONS AND USAGE

Urelle®  is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients is possible. Risk - benefit should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

WARNINGS

If rapid pulse, dizziness, or blurring of vision occurs, discontinue use immediately.

Patients should be advised that urine will be colored blue when taking this medication.

Do not exceed recommended dosage.

PRECAUTIONS

Cross sensitivity and/or related problems  - patients intolerant of belladonna alkaloids or salicylates may be intolerant of this medication also. Delay in gastric emptying could complicate the management of gastric ulcers.

DOSAGE AND ADMINISTRATION

Adults – One tablet orally 4 times per day followed by liberal fluid intake.

Pediatric – Dosage must be individualized by a physician for older children. Urelle® is not recommended for use in children 6 years of age or younger.

HOW SUPPLIED

Urelle® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 66663-219-01).

Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in a tight, light resistant container as defined in the USP.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Distributed by: Pharmelle a division of AZUR PHARMA, INC. • 1818 Market Street, Suite 2350 • Philadelphia, PA 19103 • www.azurpharma.com

Manufactured by: PureTek Corporation. San Fernando, CA 91340

Urelle®  is a registered trademark of Azur Pharma International II Limited.

To report a serious adverse event or obtain product information, contact (800) 890 3098.

Rx Only

URLLw-10-01

PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

Description: Urelle® tablets for oral administration
are supplied as navy blue round tablets with
"A-002" debossed on one side.

Each Tablet Contains:

Hyoscyamine Sulfate 0.12 mg
Methenamine 81.0 mg
Methylene Blue 10.8 mg
Phenyl Salicylate 32.4 mg
Sodium Phosphate Monobasic 40.8 mg

Dosage: Adults - one tablet orally 4 times per day
followed by liberal fluid intake. Pediatric - Dosage
must be individualized by a physician for older
children. Urelle® is not recommended for use in
children 6 years of age or younger.

Note: Patients should be advised that urine will be
colored blue when taking this medication.

Storage: Store at controlled room temperature
15°-30°C (59°-86°F). Dispense in a tight, light
resistant container as defined in the USP.

KEEP OUT OF THE REACH OF CHILDREN.

 

90 TABLETS                     NDC 66663-219-01

urelle®

Urinary Antiseptic

Rx Only

Dist. by: Pharmelle, a division of AZUR PHARMA, INC.

1818 Market Street, Suite 2350

Philadelphia, PA 19103

www.azurpharma.com

Mfd. by: PureTek Corporation

San Fernando, CA 91340

 

Urelle is a registered trademark of Azur Pharma International II Limited.

To report a serious adverse event or obtain product information, contact (800) 890 3098.

URLLt-10-02

Bottle Label

Bottle Label


URELLE 
urelle   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66663-219
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.12 mg
METHENAMINE (METHENAMINE) METHENAMINE 81 mg
METHYLENE BLUE (METHYLENE BLUE) METHYLENE BLUE 10.8 mg
PHENYL SALICYLATE (PHENYL SALICYLATE) PHENYL SALICYLATE 32.4 mg
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (PHOSPHATE ION) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 40.8 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
FD&C BLUE NO. 2  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POLYVINYL ALCOHOL  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color BLUE (Navy) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code A002
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 66663-219-01 90 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2002

Labeler - Azur Pharma Inc. (805611071)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 031678746 MANUFACTURE
Revised: 06/2010 Azur Pharma Inc.